BEUDAMED
    FDA Enforcement Class II Terminated

    Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.

    Recall: Z-2126-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2126-2016
    Event ID
    73198
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    November 25, 2015
    Classification Date
    July 5, 2016
    Termination Date
    November 14, 2018
    Address
    4500 Riverside Dr, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.

    Reason

    Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".

    Code Info

    Part Number 530.710, Serial Numbers 101066, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101075, 101076, 101077, 101078, 101079, 1011080, 101081, 101082, 101083, 101084, 101085

    Distribution

    US Distribution to the state of : VA and Internationally to: Thailand and UK

    Quantity

    20 hand pieces